Phase 3
Completed N=157
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03875482 ↗Enrolled (actual)
157
Serious AEs
0.6%
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 — 62.9; 3.8 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
15citations · ~4 / year
Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis.
Summary
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
Linked Publications
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Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 |
62.9; 3.8 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 |
78.1; 9.6 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 |
38.1; 1.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16 |
39.0; 1.9 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
- Participant meets following disease activity criteria:
- Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
- Candidate for systemic therapy as assessed by the investigator.
Exclusion Criteria
- Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- Participant has previous exposure to risankizumab.
Data sourced from ClinicalTrials.gov (NCT03875482) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.